Prasinezumab for Early Parkinson's Disease
(PADOVA Trial)

Recruiting in Palo Alto (17 mi)

+129 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Hoffmann-La Roche

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing an IV drug called prasinezumab in people with early-stage Parkinson's Disease who are already on stable medication. The drug aims to slow down the disease by attaching to a harmful protein in the brain. Researchers want to see if it works effectively.

Eligibility Criteria

This trial is for people with early Parkinson's Disease (PD) who've been diagnosed for 3 months to 3 years, are on stable PD meds, and can use a smartphone app and smartwatch to track symptoms. They should be in the early stages of PD without other neurological diseases or significant health issues like uncontrolled hypertension or recent substance abuse.

Inclusion Criteria

Willingness and ability to wear a smartwatch to measure PD-related motor signs

I have been on stable Parkinson's disease medication for at least 3 months.

My Parkinson's is in the early stages (I or II) without medication.

+6 more

Exclusion Criteria

I have had serious heart problems in the past year.

My high blood pressure is not under control.

I have been diagnosed with Parkinson's disease dementia.

+7 more

Participant Groups

The study tests Prasinezumab, an IV drug against a placebo in participants with early-stage PD. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug versus placebo. Participants must be on stable PD medication throughout the study.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PrasinezumabExperimental Treatment1 Intervention

Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W). Participants will enter into the optional Open Label Extension (OLE) once the double-blind treatment period has completed.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo as an IV infusion Q4W.